Quality Engineer 2 - R&D Operations

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

MilliporeSigma is seeking a Quality Engineer to support the Quality and Site Operations team in Bedford, MA by maintaining the R&D Quality Management System in alignment with ISO 9001:2015. The role leads quality audits to evaluate compliance, surface risk, and identify improvement opportunities to strengthen site and organizational performance. In addition to audit leadership, this role flexes to support site operations activities and site events as needed, partnering cross-functionally to help the site execute priorities and drive continuous improvement.

Responsibilities:

• Implement and maintain the ISO 9001:2015 QMS for the R&D environment.
• Lead annual internal audits, including planning, execution, and follow-up.
• Prepare detailed audit reports with evidence, risk-based findings, and actionable recommendations.
• Manage audit findings in Veeva; review deviations and CAPAs to ensure timely closure and effectiveness.
• Develop, review, and maintain site-relevant SOPs and supporting documents.
• Coach R&D stakeholders on audit readiness and documentation standards.
• Deliver training and audit preparation sessions to strengthen readiness and consistency.
• Support cross-functional initiatives and site operational needs, including coordinating and executing site events and activities as needed.
• Drive continuous improvement by identifying opportunities to simplify, strengthen controls, and improve operational effectiveness.
• Support site operations initiatives, including sustainability, digitalization, and automation projects, by coordinating quality input, documentation, and cross-functional follow-through.
• Perform other related duties as needed in support of site and business priorities.

Who You Are:

Minimum Qualifications:

• Bachelor’s degree in a Science or Engineering field
• 3+ years of Quality Engineering experience, including at least 2 years of experience as an Auditor
• 2+ years of experience with CAPA management, deviations, and quality systems
• 2+ years of experience with electronic quality systems such as TrackWise

Preferred Qualifications:

• Excellent communication skills with the ability to influence and collaborate across all levels
• Detail-oriented, highly organized, and strong in problem-solving and follow-through
• Product development experience
• ASQ CQA certification
• Collaborative and motivated team player, always looking to share and advance best practice
• Proven hands-on experience auditing to ISO 9001:2015 standards
• Proven experience leading audits, including planning, execution, reporting, and follow-up
• Ability to write clear, evidence-based audit reports and communicate findings with professionalism and firmness
• Ability to identify systemic issues, assess risk, and link observations to process and QMS controls
• Experience with electronic QMS tools (e.g., document control, training, deviations/nonconformance, CAPA)
• Comfortable working independently and prioritizing multiple quality tasks and follow-ups
• Comfortable shifting between auditing work and broader site support needs in a dynamic environment

Pay Range for this position: $83,200 - $124,800

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!